NCT06170749

Brief Summary

To develop and validate a prediction model for estimating the short and long-term risk of anemia after bariatric surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

7.3 years

First QC Date

December 6, 2023

Last Update Submit

July 4, 2025

Conditions

AnemiaBariatric Surgery

Keywords

AnemiaBariatric surgeryPrediction model

Outcome Measures

Primary Outcomes (1)

  • AUCs of the prediction model at 1, 3, 5 years

    This metric shows the discrimination ability of the prediction model.

    5 years

Secondary Outcomes (1)

  • Brier score

    5 years

Other Outcomes (1)

  • AUCs of the prediction model in different subgroups

    5 years

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study aims to include patients with obesity who will undergo bariatric surgery.

You may qualify if:

  • aged between 16-70 years;
  • body mass index (BMI) ≥ 27.5 kg/m2;
  • complete preoperative and follow-up data.

You may not qualify if:

  • vegetarian;
  • other bariatric procedures;
  • renal failure at baseline;
  • postoperative bleeding (it was defined as a drop in hemoglobin levels \> 3 g/dL or a confirmed blood loss requiring treatment after surgery);
  • incomplete preoperative and follow-up data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuntao Nie

Beijing, 100029, China

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yuntao Nie, M.D.

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

September 1, 2017

Primary Completion

December 31, 2024

Study Completion

May 31, 2025

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

CN(1)